Medical Device GMP PD631847

Topics: Quality, Safety & Maintenance

The FDA requires employees to be trained in the current GMP as it  relates to the employee's functions to help assure the safety and efficacy of medical devices.

Objectives

  • Understanding regulatory framework: Gain a thorough understanding of the regulatory framework governing GMP requirements for medical devices, as outlined by the Quality System Regulation (QSR) in Title 21 CFR Part 820.
  • Compliance with CGMP requirements: Learn how to interpret and comply with the specific requirements outlined in the QSR, which govern the methods, facilities, and controls used in the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for human use.

Materials Provided

  • 365 days of online single-user access (from date of purchase) to the approximately 15 hours of instruction
  • Continuous assessment to check knowledge and application of key concepts
  • Follow-up to your content questions

Is this On Demand Course for You?

This is course is for professionals working in the medical device manufacturing industry, as well as quality assurance and regulatory compliance inspectors. 

For More Details

Email CustomerService@sae.org, or call 1-877-606-7323 (U.S. and Canada) or 724-776-4970 (outside US and Canada).

Access Period: 365 Days

Duration: 12 Hours
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